Ipsen said Friday its investigational asset fidrisertib flunked a pivotal mid-stage study in fibrodysplasia ossificans progressiva (FOP), an ultra-rare bone condition, prompting the company to shelve the trial.The Phase II FALKON study enrolled 113 patients aged five years and older with the R206H ACVR1 mutation or other progressive heterotopic ossification (HO)-associated FOP variants to date. Participants were randomised to receive either a high- or low-dose of fidrisertib, or placebo, with an

An investment from the Coalition for Epidemic Preparedness Innovations (CEPI) has breathed new life into Moderna's pandemic influenza vaccine programme, which had been facing an uncertain future since the US government withdrew its support earlier this year. Thanks to a $54.3-million award from CEPI, Moderna will now move its mRNA-based H5 avian influenza vaccine, mRNA-1018, into a Phase III trial.In May, the drugmaker reported positive immunogenicity findings from a Phase I/II trial of the cand

- South Korean biotech company secures US$8 million in upfront payment for the joint commercialization of the stem cell therapy CARTISTEM® targeting the Japanese knee osteoarthritis market. SEOUL, South Korea, Dec. 19, 2025 /PRNewswire/ -- MEDIPOST Co., Ltd. (KOSDAQ 078160), a fully integrated cell therapy biotechnology company, today announced a multi-year partnership with Japan's Teikoku Seiyaku Co., Ltd. for the commercialization of CARTISTEM®, an innovative treatment for knee osteoarthritis

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice This guidance is intended to provide information about FDA inspections of clinical investigators conducted under FDA’s Bioresearch Monitoring (BIMO) Program. This document supersedes FDA’s Information Sheet Guidance, " FDA Inspections of Clinical Investigators ," dated January 2006. This document has been revised to provide updated in

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been accepted by the Center for Drug Evaluation (" CDE")of the National Medical Products Administration (" NMPA") of the PRC. It is intended for the treatment of adults with unresectable advanced or metastatic cholangiocarcinoma (CCA) who have received at least one prior systemic treatment and FGFR inhibitor

PALO ALTO, Calif., Dec. 18, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock, which includes 1,043,478 shares sold pursuant to the underwriters' exercise in full of their option to purchase additional shares, at a price to the p

A US congressional commission is escalating its warning that the US could soon be eclipsed by China in biotech, after lawmakers took up some of its recommendations earlier this year. In a report released early Friday morning, the National Security Commission on Emerging Biotechnology said that it had previously identified a three-year period for decisive action , but new evidence indicates that this window is closing faster than anticipated, with global power dynamics at stake. “The urgency unde

BEIJING, Dec. 18, 2025 /PRNewswire/ -- Syneron Bio, an macrocyclic peptide drug discovery company driven by intelligent high-throughput platform, has successfully completed its Series A and A+ financing rounds, raising close to USD 100 million in total. Top-tier investors participated in the round, including AstraZeneca, AZ-CICC Healthcare Investment Fund, Pfizer Biotech Development Investment Fund, GL Ventures, 5Y Capital, Sinovation Capital, Lenovo Capital, Gree Capital and KHK fund. Dr. Xiao

Researchers from The Institute of Cancer Research, London, will contribute to a £13.7 million research consortium aimed at developing new brain tumour treatments, following an announcement by the NIHR today. The funding will establish the NIHR Brain Tumour Research Consortium. The consortium is a national partnership uniting hospitals, universities, cancer centres and charities along with patients. This is a coordinated UK-wide effort to transform outcomes for people living with brain tumours an

iStock, Suchat longthara The fatalities were attributed to interstitial lung disease, a known side effect of Daiichi Sankyo’s DXd-based antibody-drug conjugates. A spokesperson declined to say how many patients died. The FDA has placed a partial clinical hold on Merck and Daiichi Sankyo’s late-stage development program for their antibody-drug conjugate ifinatamab deruxtecan after “a higher than expected” number of deaths were detected, according to several media reports on Thursday. The compa